At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 49 enrolled
Drug / intervention
Brexpiprazoledrug
Likely dose
Brexpiprazole 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Protocol 331-13-006: An Exploratory, Multicenter, Open-label, Monotherapy, Flexible-dose Brexpiprazole (OPC 34712) Trial in Adults With Early Episode Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Dec 17, 2013·Updated Mar 29, 2016
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole for Schizophrenia. Completed, enrolled 49 participants across 22 sites.
Detailed Summary
The purpose of this study is to investigate the effects of flexibly dosed Brexpiprazole monotherapy in the improvement of early-episode schizophrenia through the assessment of social functioning, efficacy, and tolerability. Early-episode schizophrenia is defined as episodes occurring ≤ 5 years after the onset of the first episode.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
CollaboratorsOtsuka Pharmaceutical Co., Ltd.
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartNov 2013
First PostedDec 2013
Primary CompletionSep 2014
Study CompletionOct 2014
TodayJul 2026
First PostedDec 17, 2013
Enrollment StartNov 1, 2013
Primary CompletionSep 1, 2014
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.5 years ago
Interventions
Brexpiprazoledrug
Treatment (16 weeks) Up to 4 mg/day, once daily dose, tablets, orally